Theta-Burst-Stimulation in Recurrent Stroke Recovery

University Hospital of Cologne

Status and phase

Unknown

Phase 2

Conditions

Stroke

Neurorehabilitation

Treatments

Device: Magstim Super Rapid2 System

Study type

Interventional

Funder types

Other

Identifiers

NCT03337867

U1111-1204-6783

Details and patient eligibility

About

The present study aims at investigating the effects of intermittent theta-burst stimulation (iTBS) for motor recovery in recurrent stroke patients. Therefore a daily intervention of repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy is compared to a control condition, sham stimulation combined with subsequent physiotherapy. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.

Full description

To date, the majority of neuromodulation approaches aiming at improving motor recovery after stroke are limited to patients with first-ever ischemic stroke. Therefore, rehabilitation of recurrent stroke mainly includes physiotherapy and occupational therapy. Yet, particular these patients retain movement impairment relevant for activities of daily living.

By using repetitive transcranial magnetic stimulation (rTMS), it is possible to promote recovery of connectivity between brain regions, particularly after stroke and thereby improve motor performance. Previous data indicate that intermittent theta-burst stimulation (iTBS), a protocol of neuromodulation, enhances the effects of subsequent motor training in early rehabilitation after stroke.

The current study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery in recurrent stroke, compared to control condition, physiotherapy after sham stimulation. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.

Enrollment

60 estimated patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

written consent
age: 40-90 years
recurrent stroke
hemiparesis with impaired hand motor function

Exclusion criteria

Subjects who are legally detained in an official institute (§20 MPG)
Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)
Medication pump (e.g. insulin pump)
Metal splinters in eye or head
Pregnancy / breastfeeding
Severe Neurodegenerative disease
Severe Neuroinflammatory disease
History of seizures / epilepsy
Physical addiction to alcohol, medication, or drugs (excluded: nicotine)
Insufficient compliance
Present or past malignant tumor involving the central nervous system
Severe Psychiatric disease
Frequent medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization